Trial Information

This study is designed to evaluate the feasibility of using blueberry powder (rich in
anthocyanidins) as an adjunct therapy with the conventional chemotherapy drug
paclitaxel/docetaxel for treatment of NSCLC. The study is based on information from
published studies in which blueberry anthocyanidins (bioflavonoids which give blueberries
their color) have been shown to regulate a vast array of molecular targets, and on our own
exciting and compelling preliminary data showing that blueberry anthocyanidins elicited
potent synergistic chemo-sensitizing effects in two highly aggressive non-small cell lung
cancer (NSCLC) cell lines.

- lesion(s) used for determination of response were not previously irradiated or
have increased in size since the completion of radiotherapy

- the patient has recovered from any acute effects of the radiotherapy

- radiotherapy was completed at least 4 weeks prior to screening

6. Part 1: Have at least non-measurable evaluable disease (e.g., lesions which are
smaller than the minimum size required for measurability; other non-measurable
lesions such as bone metastases, malignant pleural effusion)

7. Part 2: Have measurable disease, defined as at least 1 lesion that can be accurately
measured in at least 1 dimension (longest diameter to be recorded) as > 10
millimeters (mm) on cross-sectional imaging (where the CT slice thickness is no
greater than 5 mm) or at least 20 mm by standard techniques; positron emissions
tomography [PET] and ultrasound are not permitted methods for tumor measurements
under this protocol.

- Females: non-pregnant and non-lactating; surgically sterile, post-menopausal, or
patient/partner compliant with a reliable contraceptive regimen, as determined
by the Investigator, for 4 weeks prior to screening. Patients of reproductive
potential must test negative for pregnancy at screening and must agree to use a
reliable method of birth control during the study period

- Males: surgically sterile or patient/partner must agree to use a reliable
contraceptive method, as determined by the Investigator, during the study period

- The patient is willing and able to comply with the study visit schedule and
procedures, and has geographical proximity (Investigator's discretion) that
allows follow-up specified by the protocol

- For Part 1: have discontinued all prior chemotherapies, biological therapies,
and other investigational therapies for cancer for at least 4 weeks (6 weeks for
mitomycin-C or nitrosoureas) prior to study treatment and have recovered from
the acute effects of therapy

Exclusion Criteria:

1. Part 1: More than one prior chemotherapy (single biological therapy, i.e., Erlotinib
not included) regimens (approved or experimental) for NSCLC, not counting adjuvant
and neoadjuvant treatment. A regimen is defined as two or more consecutive cycles of
treatment. Part 2: Any prior chemotherapy or biological therapy (approved or
experimental) for NSCLC including adjuvant and neoadjuvant treatments

2. Treatment with another investigational drug, biological agent, or device within 4
weeks (6 weeks for biological agents) before screening or 5 half-lives of study
agent, whichever is longer

3. Patients with treated or untreated parenchymal brain metastases or leptomeningeal
disease. Brain imaging is required for symptomatic patients to rule out brain
metastases, but is not required in asymptomatic patients

6. Presence or history of malignancy other than NSCLC, carcinoma in situ of the cervix,
or non-melanoma skin cancer. In the case of other malignancies, patients may be
considered for participation if the prior malignancies were diagnosed and
definitively treated at least two years previously with no subsequent evidence of
recurrence.

7. Presence of an underlying disease state associated with active bleeding

10. Planned concomitant participation in another clinical trial of an experimental agent,
vaccine, or device

11. Patients with any other medical conditions that in the opinion of the Investigator
would make the patient unsuitable for enrollment, or could interfere with the patient
participating in or completing the study

Outcome Measure:

Outcome Description:

Completion of treatment plan by 10 patients. Feasibility and toxicity for the study will be evaluated in Part 1 of the study based on 10 patintents completing the treatment plan(20 if 2 of the intial 10 patients develop toxicities)

Outcome Time Frame:

2 years after study enrollment

Safety Issue:

Yes

Principal Investigator

Goetz H Kloecker, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

James Graham Brown Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

BCC-LUN-BIT-2

NCT ID:

NCT01426620

Start Date:

June 2011

Completion Date:

June 2017

Related Keywords:

Non-Small Cell Lung Cancer

NSCLC

blueberry

salvage therapy

docetaxel

non-small cell lung cancer

second-line

polyphenol

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Name

Location

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